510(k) Report

510(k) · Cleared

Cleared

Venes Anti Embolism Stockings

K830696510(k) TraditionalCleared Mar 31, 198324-day reviewClass II21 CFR 880.5780

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Futuro Div. Jung Corp. · DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

Cleared on Mar 31, 1983 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
Mar 31, 1983
Review
24 days
Class
Class II
Product code
DWL
Recalls
None
Predicates
0

6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared2004: 1 descendant cleared2010: 2 descendants cleared2012: 1 descendant cleared19801990200020102020
  1. This deviceK830696 Venes Anti Embolism StockingsFuturo Div. Jung Corp. · 1983
  2. Descendant · cites it directly · 5 of its ownK040353 Flight SockSsl Americas, Inc. · 2004
  3. Descendant · 2 generations on · 4 of its ownK091141 Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's…Knit-Rite, Inc. · 2009
  4. Descendant · 3 generations on · 1 of its ownK101906 Shape to Fit Compression WearTsung Hau Technology Co., Ltd. · 2010
  5. Descendant · cites it directly · 1 of its ownK090921 Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02…Beiersdorf, Inc. · 2009
  6. Descendant · 4 generations on · 0 of its ownK123085 Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM)…3M Company · 2012

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2004: 12009: 22010: 22012: 1
2004high 2 (2009) · low 0 (2005)2026

Most influential descendants

Showing 5 of 6 · See all
  • K040353Flight SockSsl Americas, Inc. · 2004 · cites it directly5descendants
  • K091141Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's Trouser SocksKnit-Rite, Inc. · 2009 · 2 generations on4descendants
  • K101906Shape to Fit Compression WearTsung Hau Technology Co., Ltd. · 2010 · 3 generations on1descendant
  • K090921Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02, 71059-00000-02…Beiersdorf, Inc. · 2009 · cites it directly1descendant
  • K123085Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM) Travel Stockings…3M Company · 2012 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K830696Venes Anti Embolism StockingsFuturo Div. Jung Corp.1983—
+1K040353Flight SockSsl Americas, Inc.2004—
+2K091141Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's Trouser SocksKnit-Rite, Inc.2009—
+3K101906Shape to Fit Compression WearTsung Hau Technology Co., Ltd.2010—
+1K090921Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02…Beiersdorf, Inc.2009—
+4K123085Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM) Travel…3M Company2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200920
201020
201210
FIG. 1 — Lineage of K830696, 1983–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DWL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040353Flight SockSsl Americas, Inc.20045
K090921Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02, 71059-00000-02…Beiersdorf, Inc.20091

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K040353 (Ssl Americas, Inc., 2004) has gone furthest, with 5 descendants of its own.

How does its category compare?

All DWL devices

DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWL

1in 2014

2007: 12009: 22010: 32011: 22012: 52013: 32014: 1
2007high 5 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWL

111in 2013

2010: 214 days median2012: 43 days median2013: 111 days median
2007high 214 (2010) · low 43 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DWL

No recall names DWL since 2007.

Adverse event reports per year · DWL

2in 2025

2007: 12009: 32010: 72011: 42012: 102013: 42014: 22015: 12017: 42018: 22019: 12020: 32021: 22022: 12023: 22025: 2
2007high 10 (2012) · low 0 (2008)2025

MAUDE reports naming product code DWL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—01
20080—00
20092—03
2010321407
20112—04
2012543010
2013311104
20141—02
20150—01
20160—00
20170—04
20180—02
20190—01
20200—03
20210—02
20220—01
20230—02
20240—00
20250—02
20260—0—
Cite this page

510(k) Report. “K830696: Venes Anti Embolism Stockings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K830696

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026